Four-way crossover study to determine the safety, tolerability, and pharmacokinetics of ECs315 administered as a single or multiple sublingual wafer and oil to healthy volunteers

Phase 1

Completed

• Conditions: Chemotherapy Induced nausea and vomiting; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12618000391279
• Lead Sponsor: BOD Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-16
• Study Completion: 2019-03-25
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Medically healthy, determined by non-clinically significant laboratory profiles, medical history, vital signs, physical examination, 12-lead ECG at screening as deemed by the Principal Investigator and/or Sponsor Medical Monitor.
- No history of cardiac disease.
- Resting heart rate, as measured by ECG in the range of 40 and 100 bpm inclusive.
- No active or chronic diseases/disorders, no history of hospitalization for illness within the six months prior to enrolment into study, and no major surgery within the 6 months prior to enrolment into study.
- Must have a body mass index in the range of 18 to 32 kg/m2 inclusive and body weight greater or equal 50 kg.
- Females must be non-pregnant, non-lactating, or postmenopausal for at least 1 year (as confirmed by follicle-stimulating hormone [FSH]), or surgically sterile for at least 6 months prior to dosing.
- Must be non-smokers for at least six months and/or not on nicotine containing products including Tobacco use (chewing or sniffing) or smoking cessation products prior to enrolment. This includes any form of inhaled tobacco including e-cigarettes. Social smokers who are otherwise healthy may be enrolled if they have not used nicotine-containing products within 2 weeks of dosing and agree to abstain for the duration of the study.

Exclusion Criteria

- History of any clinically important cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major disease, as determined by the Investigator and/or Sponsor Medical Monitor.
- Acute disease state (e.g., nausea, vomiting, diarrhoea) within 7 days of Study Day 1.
- Used cannabinoids or a cannabinoid-based medicine within 12 months prior to receiving study medication and willingness to abstain from recreational drug use during the study period.
- Admitted alcohol abuse or consumption average of more than 2 standard units per day (a standard unit equals 350 ml of beer, 50 ml of 80-proof alcohol, or one 175 ml glass of wine) or history of alcoholism within the past 2 years.
- Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies.
- Positive urine drug screen (e.g., amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, phencyclidine, ecstasy, methamphetamines, methadone and opiates) at screening or Day -1 or a history of drug abuse within the past 2 years.
- History of any clinically important severe allergic or anaphylactic drug reaction or known or suspected hypersensitivity to compounds similar to the investigational product.
- Family history of long QT-syndrome or sudden death without a preceding diagnosis of a condition that could be causative of sudden death such as coronary artery disease, congestive heart failure or terminal cancer.
- History of suicide attempt or suicidal behaviour. Any recent suicidal ideation within the last 12 months (a level of 4 or 5 for any 1 item on the scale), or who are at significant risk to commit suicide, as judged by the Investigator using the C-SSRS at screening and on admission to the clinical unit on Day -1.

Study & Design

• Study Type: Interventional
• Study Design: Not specified